You are here
Application for Fabry Disease Treatment Pulled From FDA Review
The drug, Replagal, is an enzyme replacement therapy for the disease, which causes fat to build up in the body.
Shire had filed in November for FDA approval for Replagal, "in anticipation of a quick review process," the company said.
Shire has been permitted to supply the drug to the U.S. market after manufacturing problems in 2009 led to short supplies of rival drug Fabrazyme, which is made by Genzyme, now owned by Sanofi SA. Replagal has been on the market in Europe since 2001.
The FDA said Shire has also decided to end that treatment program over the next few months, and the drug will no longer be available to U.S. patients.
Read the full article on Reuters